[Recalled] VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. — software automatically switches the lot when a vancomycin (VANC
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. |
|---|---|
| Brand / manufacturer | Ortho-Clinical Diagnostics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2066-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 May 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Ortho-Clinical Diagnostics
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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